Opioid Use Disorder in Pregnancy in Long-Term Maternal/Infant Outcomes

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Senthil Sadhasivam
Study ID
NCT03923374
Status
Recruiting
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Conditions

  • Buprenorphine Dependence
  • Opioid Use, Unspecified
  • Opioid-use Disorder

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Subutex / Buprenorphine — DRUG
    Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.
  • Fetal & Neonatal MRI — DIAGNOSTIC_TEST
    Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.
  • DNA/Genetic/Pharmacokenetic Blood Draws — DIAGNOSTIC_TEST
    Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples.

Study Details

The objective of this study is to better understand the comprehensive integration of both clinical and genetic factors that will help to identify mothers who could be at an increased risk of poor response to opioid substitution and infants at risk of significant neonatal abstinence syndrome (NAS).

Key Dates

Start date
Sep 15, 2018
Status verified
Dec 2025
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Pregnant Mothers with Opioid Use Disorder
    Planned recruitment of 200 pregnant (\<16weeks) mothers who have opioid use disorder and are taking buprenorphine
  • Arm: Pregnant Mothers
    Planned recruitment of 100 pregnant (\>16weeks) mothers who do not have any history of opioid use disorder.

Primary Outcome Measure

Incidence of opioid misuse severity using assessments [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Children's HospitalPittsburghPennsylvania15224
Senthil M Sadhasivam, MD, MPH
[email protected]
4126474484
Carly Riedmann, MPH
[email protected]
4126234147
Senthilkumar Sadhasivam, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
UPMC Children's Hospital· Pittsburgh, PA

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